Regulatory Affairs Specialist

Regulatory Affairs Specialist page is loaded## Regulatory Affairs Specialistlocations: UK - Manchester: PL - Warsawtime type: Full timeposted on: Posted 2 Days Agojob requisition id: R53322## Arxada is a global leader in innovative solutions that protect our world. Our groundbreaking technologies, in-depth regulatory know-how, manufacturing and process development help our customers to safeguard nutrition, health and infrastructure efficiently through chemistry and biotechnology that enhance sustainability. We offer a broad portfolio of ingredients and services for multiple end-markets that include Human Health & Nutrition, Home & Personal Care, Professional Hygiene, Paints & Coatings and Wood Protection.With customers in more than 100 countries, the company achieved sales of CHF 2 billion in 2024. Headquartered in Basel (Switzerland), Arxada employs 3,200 associates across 24 production sites and 14 R&D centers, all committed to our customers’ success.## Arxada is seeking a Regulatory Affair Specialist accountable to the Senior Manager Regulatory Affairs for supporting the Professional Hygiene and Home Care regulatory programme. Acting as both a thought leader and a hands-on contributor to deliver business results by ensuring that the products developed and marketed by Arxada meet strict internal standards as well as relevant EMEA regulatory requirements.The regulatory specialist will provide a high level of expertise and guidance ensuring that the regulatory strategy for the respective business and product portfolio are met. The regulatory specialist shall also provide an efficient regulatory and registration service, responsive to both internal and external customers, with a focus on the Hygiene and Home Care business (or other business unit as required).## Essential Job Functions* Leadership on all topics associated with regulatory strategy and delivery relative to the Arxada portfolio and as required by the various regulations (BPR, MDR, PPPs, REACh, CLP and other national approaches).* Deliver regulatory aspects of business-critical projects such as coordination, complication and submission of EMEA product registrations.* Manage post submission activities, with a view to achieving a favourable outcome for Arxada, including discussions with agency officials or other stakeholders.* Provide biocide, medical device and chemical policy analysis, regulatory expertise and advice to the business and to customers.* Coordinate with Marketing and Sales colleagues in all relevant geographies on strategic and commercial aspects of assigned regulatory projects.* Coordinate with R&D, Quality and Product Safety colleagues on technical aspects of assigned regulatory projects.* Monitor, assess and communicate changes to regulatory requirements and related impact on product portfolio.* Participate in industry associations, task forces or stakeholder groups. Supports benchmarking and advocacy initiatives to ensure the position of Arxada on emerging biocide and chemical legislation and policy issues are considered.* Demonstrate flexibility and adaptability to support regulatory team goals.## Requirements* PhD or degree level in natural sciences or similar and typically 5–10 year in the biocide and/or medical device industry.* Ability to grasp new concepts quickly and to assimilate/evaluate scientific data.* Ability to work under pressure and to strict deadlines with attention to detail.* Team player with ‘can do’-mentality; a strong communicator, who is flexible and self-starting with proven project management and project co-ordination skills.## Arxada has world class offering in two distinct areas:Microbial Control Solutions (MCS) focuses on threats posed by microorganisms to people and planet through five distinct business lines including Professional Hygiene, Home & Personal Care, Wood Protection, Paints & Coatings and Material Protection.Nutrition, Care & Environmental (NCE) provides materials used to manufacture composites for electronics, aerospace and other markets, as well as vitamins and nutritional ingredients, chemicals and performance intermediates, and raw materials for a wide range of high-performance applications.## Arxada is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.GB08
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